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NCT01907048 Clinical Trial

Patient and Physician Knowledge of Key Safety Messages

Anticoagulation Clinical Trial

Official title:
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01907048
Other study ID # 16167
Secondary ID XA1202
Status Completed
Phase
First received
Last updated
Start date September 15, 2014
Est. completion date April 15, 2020

Study information
Verified date April 2021
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

Recruitment information / eligibility
Status Completed
Enrollment 2227
Est. completion date April 15, 2020
Est. primary completion date February 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Inclusion criteria: Physician eligibility: - Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT. Patient eligibility: - Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
• Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure patient awareness and understanding of the key messages in the patient card.

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Bayer Janssen Research & Development, LLC, RTI Health Solutions

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire Up to 18 months
Primary Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire Up to 18 months
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